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Positive End Expiratory PressureTIPPRNCT05155371

Titration of Intraoperative PEEP in Patients Undergoing Robotic Assisted Laparoscopic Prostatectomy

A study testing Titration of Optimal Positive End-expiratory Pressure in people with Positive End Expiratory Pressure, run by Fudan University at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Optimal intraoperative positive end expiratory pressure (PEEP) improves the outcome. Optimal PEEP is not only very different among individuals, but each individual's optimal PEEP is affected by positioning, muscle paralysis, and several other factors. Several techniques have been used to determine the optimal PEEP. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Positive End Expiratory Pressure
What is being tested?
Titration of Optimal Positive End-expiratory Pressure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
95 participants
Where
2 sitesChina
Study dates
20 Oct 2021to 20 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • adult patients aged 18 years or older
  • scheduled for elective robotic-assisted laparoscopic prostatectomy(RALP)
  • ASA physical status of I-III

Who cannot join

  • acute or chronic respiratory disorders
  • pulmonary hypertension
  • neuromuscular disease
  • preoperative SpO2<95% on room air

Trial locations and contacts

2 sites in 1 country.

China2 sites
  • 270 Dongan Road, Fudan University Shanghai Cancer Center

    Shanghai, 200032

  • Fudan University Shanghai Cancer Center

    Shanghai

Other trials in China

About this study

Official title: Titration of Intraoperative Positive End-expiratory Pressure to Optimize Gas Exchange in Patients Undergoing Robotic Assisted Laparoscopic Prostatectomy

Optimal intraoperative positive end expiratory pressure (PEEP) improves the outcome. Optimal PEEP is not only very different among individuals, but each individual's optimal PEEP is affected by positioning, muscle paralysis, and several other factors. Several techniques have been used to determine the optimal PEEP. For example, electrical impedance tomography(EIT)can be performed at the bedside.However, the application of this technique requires special training, increases the workload of the care team, and the cost-efficiencyof this procedure remains to be determined.We hypothesized that optimal PEEP could be obtained by titration of intraoperative PEEP levels and FiO2with SpO2 guidance. Our secondary hypothesis was that maintenance of intraoperative optimal PEEP derived via this method improves intraoperative oxygenation and reduces the incidence of postoperative hypoxemia.We tested our hypothesis in patients undergoing robotic-assisted laparoscopic prostatectomy.

Read the detailed description

Lung-protective ventilation strategies are recommended for patients under mechanical ventilation with intermediate-risk and high-risk in order to minimize lung injury and respiratory complications of critically ill patients associated with mechanical ventilation , such as atelectasis and pneumonia. Low tidal volume (TV) had been proven protective . However, there is no consensus on what the optimal positive end expiatory pressure (PEEP) is for patients with healthy lungs undergoing general anesthesia, particularly for those who are undergoing abdominal surgery. A recent study showed that electrical impedance tomography (EIT) could be used to identify optimal PEEP, where both lungs collapse, hyper-insufflation is minimized, and the variation of optimal PEEP in patients with healthy lungs undergoing abdominal surgery is profound.Therefore, a fixed PEEP applied to all patients surely over-PEEP some and under-PEEP others. This study also demonstrates that maintaining the optimal PEEP intra-operatively not only improves intra-operative oxygenation but also reduces the incidence and severity of atelectasis post-operatively . Even though this study focuses on the improvement of physiology rather than the outcome, the benefit of intra-operative optimal PEEP is sustained for at least for one-hour post extubation. Therefore, optimized intra-operative PEEP could potentially have a positive impact onoutcomes. However, the cost-effectiveness of EIT used intraoperatively as routine practice still needs to be determined. Development of new methods which can be used intraoperatively and arecost-effective and user-friendly is an unmet demand.

Recently, Ferrando et al conducted a study in which the authors used minimal FiO2 to maintain clinically acceptable arterial blood O2 saturation by titrating PEEP. Even though this study was not randomized and sample size was insufficient to demonstrate improved outcomes, it clearly demonstrated its feasibility and safety. We hypothesize that titration of intraoperative PEEP using minimal FiO2 while maintaining clinically acceptable O2 saturation allows clinicians to identify the optimal PEEP. We will test this hypothesis on patients undegoing RALP. We chose this population because these patients have increased number of postoperative complications . Additionally, physicians are prone to using suboptimal ventilation strategies such as inappropriate tidal volumes and intraoperative PEEP in this population; therefore these patients are more likely to achieve maximal benefit with optimized intra-operative PEEP.

Being tested
Titration of Optimal Positive End-expiratory Pressure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Titration of Optimal Positive End-expiratory PressureOther

    Titration of Optimal Positive End-expiratory Pressure with two different methods

Study groups in NCT05155371
Study groupRoleWhat they receive
Optimal Positive End-expiratory Pressure obtained with Titration of Fraction of Inspiratory OxygenExperimentalObtained Optimal Positive End-expiratory Pressure obtained with Titration of Fraction of Inspiratory Oxygen and sustained the PEEP intraoperatively
Receives: Other: Titration of Optimal Positive End-expiratory Pressure
Optimal Positive End-expiratory Pressure obtained with electrical impedance tomographyExperimentalObtained Optimal Positive End-expiratory Pressure obtained with EIT and sustained the PEEP intraoperatively
Receives: Other: Titration of Optimal Positive End-expiratory Pressure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The difference of optimal PEEP titrated by two methods

    Titration result of the two groups

    Measured: within 30 minutes after trachea intubation

Secondary outcomes (4)
  1. Difference of intraoperative PaO2/FiO2 between the two groups

    intraoperative PaO2/FiO2 between the two groups

    Measured: 30,60,120 minutes after finishing PEEP titration

  2. Difference of intraoperative driving pressure, dynamic compliance between the two groups

    Difference of intraoperative driving pressure, dynamic compliance between the two groups

    Measured: 30,60,120 minutes after finishing PEEP titration

  3. Difference of lung regional ventilation between the two groups

    lung regional ventilation recorded by EIT

    Measured: 5 minutes after trachea extubation

  4. Post operation hypoxemia in PACU.

    Postoperative hypoxemia was defined as postoperative hypoxemia if SpO2<92%was detected in room air within 30 min after extubation in the PACU

    Measured: within 30 minutes after trachea extubation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2021
  2. Study start20 Oct 2021
  3. Primary completion8 Dec 2022
  4. Study completion20 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Factorial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
95 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05155371
Sponsor's protocol ID
PEEP Titration of RALP
Acronym
TIPPR
Status last verified
Feb 2023
First submitted
18 Nov 2021
Last updated
15 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Titration of Optimal Positive End-expiratory Pressure in people with Positive End Expiratory Pressure, run by Fudan University at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The difference of optimal PEEP titrated by two methods (time frame: within 30 minutes after trachea intubation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.

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